The focus of this Device role is to design/develop and commercialize semi-assembly and assembly automation solutions for syringe, auto-injector, wearable devices, etc. Organization consists of subject matter experts which have comprehensive knowledge of the commercialization process. This includes process/ product development, front end planning, capacity scale-up, capital projects definition and execution, validation, regulatory submissions, and commercial manufacturing. This group has a broad-based understanding of all the relevant areas necessary to develop pharmaceutical products, (drug, device, packaging, and performance).
Responsibilities
- A subject matter expert in Equipment and automation with emphasis on device assembly and packaging engineering
- Provide subject matter expertise and hands-on work during equipment design, FAT, SAT and validation
- Partners with operations and operations engineering, site leadership, equipment vendors, and parts suppliers to plan and coordinate new technology installations, Continuous Improvement upgrades, and overhauls.
- Performing engineering assessments, implementation of system changes and supporting engineering runs
- Develop an ongoing technical knowledge base to enhance equipment support troubleshooting and reduce downtime losses on equipment issues.
- Extensive experience of structured problem solving and troubleshooting techniques.
- Strong analytical and decision-making skills
- Efficient work method with a focus on timelines & due dates
- Operations/Manufacturing engineering experience in a manufacturing/process engineering capacity with demonstrated expertise in continuous improvement and Machine performance efficiency.
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